Associate Director of Process Development and Documentation | Clinical Quality Assurance (CQA)

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Professional Summary: A highly experienced Clinical Quality Assurance professional with over 10 years of expertise in developing and maintaining clinical research SOPs, process development, and compliance for clinical-stage pharmaceutical companies. Proven leader with strong technical writing skills, capable of working cross-functionally to ensure adherence to industry standards and regulatory requirements. Experienced in managing audits, inspections, and continuous improvement of the Quality Management System (CQMS).

Key Skills & Expertise:

• Process Development & Documentation: Expertise in developing and maintaining GCP, GLP, and GVP processes and SOPs. Adept at mapping and documenting clinical processes for clinical trials.
• SOP Writing & Compliance: Strong experience in developing and reviewing SOPs, ensuring compliance with regulatory guidelines, and maintaining review timelines.
• Inspection & Audit Support: Expertise in preparing for regulatory inspections (e.g., FDA, EMA) and supporting GCP, GLP, and GMP inspections. Experience in qualification audits of clinical service providers, investigator sites, and internal audits.
• Non-Compliance & CAPA Management: Skilled in leading non-compliance event investigations and implementing corrective and preventive actions (CAPA). Focus on trends such as protocol deviations, safety, and other clinical data.
• Leadership & Mentorship: Proven ability to lead cross-functional teams, mentor junior staff, and promote talent development within the Clinical Quality Assurance team.
• Quality Metrics & Trend Analysis: Proficient in performing quality metric analysis to monitor clinical process deviations and CAPA effectiveness.
• Industry Knowledge & Regulatory Trends: In-depth understanding of regulatory changes and industry trends related to clinical development and GCP, GLP, GVP compliance.

Professional Experience:

• Led the development and documentation of GCP, GLP, and GVP SOPs, ensuring alignment with regulatory requirements and best industry practices.
• Collaborated with Clinical Development teams to create and implement processes supporting clinical trials, focusing on quality assurance and compliance.
• Managed cross-functional teams responsible for the creation and review of clinical SOPs and guidance documents.
• Actively supported inspection readiness and prepared teams for regulatory inspections, ensuring compliance and mitigating risk.
• Conducted audits of clinical documentation and service providers, including TMF and CSR reviews, ensuring adherence to SOPs and regulatory guidelines.
• Led investigations into non-compliance events, developing and implementing CAPAs to address protocol deviations and safety issues.
• Spearheaded the continuous improvement of the Quality Management System (CQMS), overseeing the creation and revision of SOPs and training programs.
• Provided mentorship and development opportunities for junior team members, fostering a collaborative and growth-oriented environment.
• Supported the development and implementation of GCP, GLP, and GVP SOPs, collaborating with clinical teams to ensure compliance with industry standards.
• Led the preparation for regulatory inspections, ensuring clinical trial documentation met all regulatory agency requirements.
• Performed quality metric analysis, identifying trends and ensuring corrective actions were implemented to improve compliance and reduce non-compliance events.
• Assisted in the management and growth of the Clinical Quality Assurance team, contributing to team building, recruitment, and staff development.

Education:

Bachelor of Science (BS) in Biological Sciences (or related field)

Technical Skills:

• Microsoft Office (Word, Excel, PowerPoint): Advanced proficiency.
• Process Development Tools: Experienced in using industry-standard tools for process mapping and documentation.